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Advanced Drug Delivery Reviews (v.59, #15)
The effects of pharmaceutical excipients on drug disposition by Talia R. Buggins; Paul A. Dickinson; Glyn Taylor (pp. 1482-1503).
Many new chemical entities are poorly soluble, requiring the use of co-solvents or excipients to produce suitable intravenous formulations for early pre-clinical development studies. There is some evidence in the literature that these formulation components can have significant physiological and physicochemical effects which may alter the distribution and elimination of co-administered drugs. Such effects have the potential to influence the results of pre-clinical pharmacokinetic studies, giving a false impression of a compound's intrinsic pharmacokinetics and frustrating attempts to predict the drug's ultimate clinical pharmacokinetics. This review describes the reported effects of commonly used co-solvents and excipients on drug pharmacokinetics and on physiological systems which are likely to influence drug disposition. Such information will be useful in study design and evaluating data from pharmacokinetic experiments, so that the potential influence of formulation components can be minimised.
Keywords: Excipients; Formulation; Pharmacokinetics; Metabolism; Surfactants
Poly(2-oxazolines) in biological and biomedical application contexts by Nico Adams; Ulrich S. Schubert (pp. 1504-1520).
Polyoxazolines of various architectures and chemical functionalities can be prepared in a living and therefore controlled manner via cationic ring-opening polymerisation. They have found widespread applications, ranging from coatings to pigment dispersants. Furthermore, several polyoxazolines are water-soluble or amphiphilic and relatively non-toxic, which makes them interesting as biomaterials.This paper reviews the development of polyoxazoline-based polymers in biological and biomedical application contexts since the beginning of the millennium. This includes nanoscalar systems such as membranes and nanoparticles, drug and gene delivery applications, as well as stimuli-responsive systems.
Keywords: Polyoxazoline; Biomaterials; Self-assembly; Drug delivery; Gene delivery; Stimuli-responsive polymers
Current challenges in non-invasive insulin delivery systems: A comparative review by El-Sayed Khafagy; Mariko Morishita; Yoshinori Onuki; Kozo Takayama (pp. 1521-1546).
The quest to eliminate the needle from insulin delivery and to replace it with non- or less-invasive alternative routes has driven rigorous pharmaceutical research to replace the injectable forms of insulin. Recently, various approaches have been studied involving many strategies using various technologies that have shown success in delivering insulin, which are designed to overcome the inherent barriers for insulin uptake across the gastrointestinal tract, mucosal membranes and skin. This review examines some of the many attempts made to develop alternative, more convenient routes for insulin delivery to avoid existing long-term dependence on multiple subcutaneous injections and to improve the pharmacodynamic properties of insulin. In addition, this article concentrates on the successes in this new millennium in developing potential non-invasive technologies and devices, and on major new milestones in modern insulin delivery for the effective treatment of diabetes.
Keywords: Non-invasive delivery system; Modern insulin delivery; Administration routes; Marketed products; Formulation technologies; Future patents
3D lithographically fabricated nanoliter containers for drug delivery by Christina L. Randall; Timothy G. Leong; Noy Bassik; David H. Gracias (pp. 1547-1561).
Lithographic patterning offers the possibility for precise structuring of drug delivery devices. The fabrication process can also facilitate the incorporation of advanced functionality for imaging, sensing, telemetry and actuation. However, a major limitation of present day lithographic fabrication is the inherent two-dimensionality of the patterning process. We review a new approach to construct three dimensional (3D) patterned containers by lithographically patterning two dimensional (2D) templates with liquefiable hinges that spontaneously fold upon heating into hollow polyhedral containers. The containers have finite encapsulation volumes, can be made small enough to pass through a hypodermic needle, and the 3D profile of the containers facilitates enhanced diffusion with the surrounding medium as compared to reservoir systems fabricated in planar substrates. We compare the features of the containers to those of present day drug delivery systems. These features include ease of manufacture, versatility in size and shape, monodisperse porosity, ability for spatial manipulation and remote triggering to release drugs on-demand, the incorporation of electronic modules, cell encapsulation, biocompatibility and stability. We also review possible applications in drug delivery and cell encapsulation therapy (CET). The results summarized in this review suggest a new strategy to enable construction of “smart”, three dimensional drug delivery systems using lithography.
Keywords: Drug delivery; Lithography; Cell encapsulation; On-demand release; Self-assembly; Containers
Directed evolution for drug and nucleic acid delivery by Kaoru Hida; Justin Hanes; Marc Ostermeier (pp. 1562-1578).
Directed evolution is a term used to describe a variety of related techniques to rapidly evolve peptides and proteins into new forms that exhibit improved properties for specific applications. In this process, molecular biology techniques allow the creation of up to billions of mutants in a single experiment, which are then subjected to high-throughput screening to identify those with enhanced activity. Applications of directed evolution to drug and gene delivery have been recently described, including those that improve the effectiveness of therapeutic enzymes, targeting peptides and antibodies, and the effectiveness or tropism of viral vectors for use in gene therapy. This review first introduces fundamental concepts of directed evolution, and then discusses emerging applications in the field of drug and gene delivery.
Keywords: Molecular evolution; Directed evolution; Antibody affinity maturation; Viral gene therapy; ADEPT; GDEPT